Medical Device Documentation and Data Management Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will review FDA’s regulations related to suppliers in manufacture of drugs, biologics and medical devices. It will discuss the current regulations, guidance documents and best practices for supplier management and enforceable quality agreement using case studies for a variety of scenarios. Common FDA audit findings will be discussed.

This medical device webinar will discuss strategies for meeting the Post Market Surveillance requirements as described in Annex X of the MDD (MDD 93/42/EEC, updated per the 2007/47/EEC M5 amendment, Annex 1: Essential Requirements), MEDDEV 2.7.1, Dec 2009 and ISO 14155.

This webinar will focus on the new requirements of EU Medical Device Directive Essential Requirements Checklist (ERC). It will also explain the relationship between ERC, Clinical Evaluation Report and Technical File.

This training program will furnish attendees with an overview of the EU vigilance system and the understanding and tools necessary for effective QMS implementation. It will also provide an implementation checklist for the vigilance system.

This webinar will discuss the disclosure requirements for clinical investigators under the Sunshine Act. It will discuss the details of the processes; provide templates for reporting formats; and timelines for reporting.

This webinar will discuss requirements and compliance under the applicable FDA regulations for medical device reporting (MDR), recall and reports of corrections and removals in the US. It is designed to help the audience develop, maintain and implement adequate procedures.

This regulatory training will help attendees understand key benefits for implementing and maintaining an effective global regulatory plan. Attendees will also gain exposure to the elements and a methodology for global regulatory plan development and maintenance.

This medical device webinar will discuss the FDA guidance on Mobile Medical Applications and provide clarification on the primary points of the guidance.

This quality system regulation training will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to complying with 21 CFR Part 820.

The webinar will focus on the amendments made to the Blue Book Memorandum #G95-1 Use of International Standards ISO-10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.” It will help attendees stay updated with the current trends set out by the amendments to the guideline and help them draft guidance documents that will impact their business.

This training program will discuss why it is important for you to be better aware of and to become better acquainted with FDA inspection best practices. In particular, the webinar will detail a list of Dos and Don’ts before, during and after the inspection.

This training program will detail best practices for documentation, list types of documents, and highlight key documentation requirements. Documentation is essential where FDA and other health authority regulations impose a special recordkeeping burden. In these industries, documentation serves both the scientific and compliance needs, and Good Documentation Practices (GDPs) are a set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.

This training program on lean documents will present a fresh departure from general practices, while building upon proven principles. The theory of lean documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and push systems, many traditional document practices are artifacts of a flawed approach. This webinar will highlight how lean configuration comes from the same principles, and utilizes the unique power of software solutions to take over functions that had previously burdened controlled paper documents.

This training program will discuss the basics of the Medical Device Reporting (MDR) regulation and review the process for preparing and submitting Electronic Medical Device Reports (eMDRs).

This webinar will teach attendees how to prepare for, manage, and follow up on FDA inspections. It will discuss common pitfalls to avoid during an inspection.

This webinar will help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings.

This FDA guidance training on RUO (Research Use Only) and IUO (Investigational Use Only) products will enumerate FDA requirements for research use only and investigational use only IVD products. The webinar instructor, an industry expert, will highlight appropriate labeling and distribution practices for RUO and IUO products and detail instructions for use of an IVD product labeled RUO or IUO.

The introduction of Vanessa’s Law in late 2014 has significantly changed the enforcement landscape, providing for the possibility of higher penalties than ever before in Canada. This training program will offer an overview of the new law and its potential impact on industry.

This webinar will provide attendees an overview of the relevant statutes, including the Competition Act, Food and Drugs Act and relevant regulations and information about the existence and operation of Canadian advertising pre-clearance agencies. The rules around advertising and marketing health products will be explained using examples, and hot topics in advertising and marketing will be covered, including the use of social media, testimonials and endorsements.

This course will instruct attendees on establishing an approach to process control within each unit of operation to generate overall process control needed for validation. The webinar instructor, an FDA expert, will enumerate the importance of variation in enhancing a validated means of operation and the parameters that can cause variability. The Randomized Block statistical model will also be analyzed for effective validation.